MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, or daraxonrasib, for use in certain adult patients with metastatic pancreatic adenocarcinoma. This targeted therapy was approved on August 26, 2026, providing a new option for patients. The authorization specifically includes adults who have previously received at least one systemic treatment and those ineligible for multiagent systemic therapy. The drug was developed by Revolution Medicines and targets the RAS GTPase family.
The approval was based on data from RASolute 302, a Phase 3 trial involving 500 adults in a randomized, open-label, multicenter study. Participants had metastatic pancreatic adenocarcinoma that progressed following one prior systemic therapy. Researchers allocated 248 patients to receive daraxonrasib and 252 to a chemotherapy regimen selected by their physicians. The median overall survival for those treated with daraxonrasib was 13.2 months, compared to 6.7 months for the chemotherapy group. The FDA reported a hazard ratio for death of 0.40.
In addition to overall survival, progression-free survival also saw notable improvement across the entire study population. Patients on daraxonrasib experienced a median progression-free survival of 7.2 months, whereas those on standard chemotherapy had 3.6 months. The objective response rate was 30% with daraxonrasib and 11% with chemotherapy. These differences in overall survival, progression-free survival, and response rate were deemed statistically significant. The findings support the use of daraxonrasib in patients whose metastatic disease has already been treated systemically.
Targeted medication interferes with RAS signaling pathway
Daraxonrasib is designed to inhibit RAS proteins by blocking their active forms, which promote tumor development. Mutations in RAS are found in more than 90% of pancreatic ductal adenocarcinomas. The drug is administered orally at a dose of 300 milligrams once daily, continuing until disease progression or unacceptable toxicity occurs. The approval applies to metastatic pancreatic adenocarcinoma and does not specify a RAS mutation as a requirement for prescribing.
Safety data from the Phase 3 trial indicated that adverse events were experienced by all patients who received daraxonrasib. Grade 3 or higher adverse events affected 61.8% of the daraxonrasib group and 69.6% of the chemotherapy group. Discontinuation due to treatment-related adverse events occurred in 1.2% and 11.2% of patients, respectively. Common side effects included rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and bleeding. The prescribing information also notes several serious warnings and precautions.
Accelerated review under priority programs
The safety warnings encompass skin and soft tissue toxicity, oral disorders, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. The label also cautions about embryo-fetal toxicity. The FDA expedited the review process using several programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency announced that it approved the application approximately 6.5 months ahead of schedule. Daraxonrasib also received Breakthrough Therapy and Orphan Drug designations.
The FDA utilized Project Orbis, facilitating collaboration with other national regulators on oncology submissions. Health Canada participated in the review, along with European and Japanese regulators as official observers. The FDA indicated that applications may still be under review elsewhere. This approval grants Revolution Medicines its Rasonque authorization for this specific U.S. patient group. For patients with previously treated metastatic pancreatic adenocarcinoma, the key Phase 3 outcome was a median overall survival of 13.2 months compared to 6.7 months with chemotherapy.